Senior Regulatory Affairs Specialist - Electrophysiology (on-site)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

The Opportunity

We are recruiting for a Senior Regulatory Affairs Specialist to join our team on-site in our St. Paul or Plymouth, MN locations. In this role, you will lead the preparation and submission for regulatory approvals and identify and resolve problems. You will provide regulatory guidance to cross-functional partners in support of various programs.

What You’ll Work On

• Prepares robust regulatory applications to achieve departmental and organizational objectives.
• Creates, reviews and approves engineering change orders.
• Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team.  Provides guidance and expertise.
• Acts as liaison between the Company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail.
• Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems.  Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
• Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations.
• Interfaces directly with FDA and other regulatory agencies.
• Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
• Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
• Compile, prepare, review and submit medical device submissions to regulatory agencies
• Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
• Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Provides mentoring and leadership to other Regulatory team members

Required Qualifications

• Bachelor's degree or an equivalent combination of education and work experience 
• Minimum 3 years’ experience in a regulated industry (e.g., medical products, nutritionals). 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Experience with submissio